Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00960232
Other study ID # UIT-ENDO-2009-1
Secondary ID
Status Completed
Phase Phase 3
First received August 14, 2009
Last updated September 3, 2012
Start date September 2009
Est. completion date December 2010

Study information

Verified date September 2012
Source University of Tromso
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines Agency
Study type Interventional

Clinical Trial Summary

There are numerous indications for a relation between low serum levels of 25(OH)D and blood pressure, lipid levels, frequency of infections and tendency towards depression. Whether it is a causal relationship it is not known, and can best be studied with a vitamin D intervention. The investigators hypothesis is that supplementation with a high dose vitamin D (40.000 IU per week) will have a beneficial effect on these parameters.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 75 Years
Eligibility Inclusion Criteria:

- men and women 30 - 75 years of age

- low serum 25(OH)D levels

Exclusion Criteria:

- diabetes

- other serious diseases

- hypercalcemia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Cholecalciferol
40.000 IU cholecalciferol per week for 6 months
placebo
placebo

Locations

Country Name City State
Norway University of Tromsø Tromsø

Sponsors (1)

Lead Sponsor Collaborator
University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depression score 6 months No
Primary Blood pressure 6 months No
Primary Lipid profile 6 months No
Primary Frequency of infections 6 months No
See also
  Status Clinical Trial Phase
Completed NCT05376865 - Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers N/A
Not yet recruiting NCT05214040 - Vitamin D Insufficiency inVestigation Among hospitaLizeD Inpatients
Completed NCT02802449 - To Study the Nutri-Genomic Response of Vit-D Supplementation in African-Americans N/A
Recruiting NCT00992797 - Diabetes Intervention Trial With Vitamin D in Subjects of Nordic and Sub-Indian Ethnicity Phase 2
Completed NCT02543671 - Investigation of Vitamin D3 Enriched, Reduced-fat Yellow Cheese Efficacy to Prevent Vitamin D Deficiency N/A
Completed NCT01240213 - Vitamin D, Diet and Activity Study N/A
Completed NCT01793402 - Vitamin D Status and the Adequacy of Vitamin D Intake in Early Preterm Infants N/A
Completed NCT00887666 - Pilot Study: Hypovitaminosis D, Hyperparathyroidism and Hypomagnesemia in Patients With Congestive Heart Failure N/A
Completed NCT05425914 - Impact of Vitamin D3 Supplementation in Non-Sjogren Dry Eye Patients With Low Serum Vitamin D Level Phase 3
Not yet recruiting NCT04829487 - The Role of Vitamin D Supplementation on Pain in Women With Primary Dysmenorrhea and Hypovitaminosis D N/A
Completed NCT05372224 - Effect of Vitamin D and Denosumab on Bone Remodelling in Women With Postmenopausal Osteoporosis N/A
Completed NCT02101151 - Effect of Vitamin D Supplementation on the Metabolic Control and Body Composition of Type 2 Diabetes Subjects in Ajman (UAE) N/A
Completed NCT00695474 - Vitamin D and Type 2 Diabetes - a Cross Sectional Study N/A
Completed NCT02434380 - Effect of Vitamin D Replacement on Maternal and Neonatal Outcomes Phase 3
Completed NCT02534714 - Analysis of Hypovitaminosis D and Osteopenia/Osteoporosis in Spinal Disease Patients Who Underwent a Spinal Fusion at Illinois Neurological Institute, Peoria, IL., a Retrospective Review From November 1, 2012 to October 31, 2014 and Prospective Pilot From July 1, 2015-June 30, 2016
Withdrawn NCT00944606 - Vitamin D Versus Placebo in the Treatment of Vague Musculoskeletal Pain in Children N/A
Recruiting NCT06138249 - Cholecalciferol and Calcifediol Are Both Useful to Improve Vitamin D Serum Levels N/A
Completed NCT05346419 - Antiresorptive Effect of Treatment With Risedronate and Vitamin D in Postmenopausal Patients N/A
Completed NCT03381378 - Vitamin D and Hand Grip Strength at 5 Years in Odense Child Cohort N/A
Completed NCT02452762 - Rapid Normalization of Vitamin D in Critically Ill Children: A Phase II Dose Evaluation Randomized Controlled Trial Phase 2